Success and Quality of Life Following Complete Pulpotomy and Root Canal Treatment

Irreversible Pulpitis Clinical Trial

Official title:

Success and Quality of Life Following Complete Pulpotomy and Root Canal Treatment in Teeth With Clinical Signs Indicative of Irreversible Pulpitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05190406
• Other study ID #: Kanagadurga
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: January 2022
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: DR. Pankaj Sangwan, MDS
• Phone: 9996112202
• Email: drps_1[@]yahoo.co.in
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the Success and quality of life following complete pulpotomy and root canal treatment in teeth with clinical signs indicative of irreversible pulpitis.

Description:

After thorough history and clinical and radiographic examination, and confirmation of eligibility for the study, risks and benefits associated with the procedure will be explained and written informed consent will be taken from the patients. Study subjects will be randomly allocated to either Complete pulpotomy or Root canal treatment Group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 1, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 60 Years

Eligibility

Inclusion Criteria:

• Mature permanent restorable mandibular molar teeth.

• Tooth should give positive response to pulp sensibility testing.

• Clinical diagnosis of irreversible pulpitis with PAI score=2.

• Tooth with probing pocket depth and mobility are within normal limits.

• Non-contributory medical history.

Exclusion Criteria:

• Teeth with immature roots.

• No pulp exposure after caries excavation.

• Bleeding could not be controlled in 6 minutes.

• Insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic.

• Absence of antagonist tooth.

• Positive history of antibiotic use in the past 1 month or requiring antibiotic prophylaxis

• Had taken analgesic in past 3 days.

• Tooth with periapical lesion visible on radiograph

Related Conditions & MeSH terms

• Irreversible Pulpitis
• Pulpitis

Intervention

Procedure:
• Pulpotomy
After achieving hemostasis, in pulpotomy group bioceramic material will be placed and then permanent restoration will be done.
• root canal treatment
Single visit root canal treatment will be done according to standard protocol.

Locations

Country	Name	City	State
India	Post graduate institute of dental sciences	Rohtak	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical success rate	Clinical success criteria No history of spontaneous pain No tenderness to palpation or percussion Normal mobility and probing pocket depth. Soft tissues around tooth are normal with no swelling or sinus tract.	6 months and one year
Primary	Radiographic success rate	Radiographic success criteria No pathosis evident on the radiograph Periapical Index score 1 or 2	6 months and one year
Secondary	Oral Health related quality of Life	Oral Health Impact Profile-14 questionnaire of score 0-4 will be used to assess the quality of life. Score 0 means never and 4 means very often affected the quality of life.	baseline to one week, 6 months and one year
Secondary	Pain assessment	Visual analogue Scale of 0 to 10 Centimetere line will be used to assess pain. Score 0 means no pain and Score 10 means maximum pain.	baseline to one week